Valved Conduit Prostheses with External Leaflet Bonding
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Solution Overview
Problem
Bioprosthetic heart valves face durability issues due to repetitive loads from leaflet opening and closing, leading to mechanical failure at the attachment points between flexible leaflets and rigid frames, primarily caused by fatigue and creep mechanisms.
Innovation Solution
A valved conduit prosthesis with leaflets externally adhered to the conduit's exterior surface using adhesive, thermal, or chemical bonding, eliminating mechanical coupling and minimizing thrombus formation through commissure gaps and a smooth interior surface, while using materials like expanded Polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP) for enhanced durability and biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If leaflets are mechanically coupled to the frame or support structure, then the leaflets are securely attached, but mechanical failure occurs at the attachment points due to fatigue and creep under repetitive loads
Solution Approach 1:
The patent replaces mechanical coupling methods (sutures, clips, or other mechanical fasteners) with adhesive bonding to attach leaflets to the frame. This substitution eliminates stress concentration points and mechanical wear at attachment interfaces, thereby preventing fatigue and creep failures while maintaining secure attachment strength.
2Strength
If the conduit interior surface has macroscopic interruptions or sinuses, then structural support is provided, but thrombus formation occurs due to flow disturbances
Solution Approach 1:
The patent applies local quality by creating a smooth interior surface in the conduit to prevent thrombus formation, while providing structural support through the frame and leaflet assembly itself. The frame provides necessary structural integrity without requiring macroscopic interruptions in the conduit interior surface, thereby eliminating flow disturbances and thrombus formation risks.
3Reliability
If adhesive bonding is used to attach leaflets to the conduit exterior surface, then mechanical coupling is eliminated and thrombus formation is minimized, but the attachment method must be optimized for durability
Solution Approach 1:
The patent employs composite materials by combining the conduit structure with a frame and leaflets using adhesive bonding. This composite approach integrates multiple materials (conduit material, frame material, leaflet material, and adhesive) to create a unified structure that achieves both durability and ease of manufacture, as the adhesive bonding process simplifies assembly compared to mechanical coupling methods.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution enhances the durability and reduces thrombus formation by distributing loads effectively and minimizing flow disturbances, thereby prolonging the lifespan of the prosthetic valve and reducing the risk of mechanical failure.
Implementation Method 1
the external portion of the at least one leaflet is adhered to the exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding
Implementation Method 2
the external portion of the at least one leaflet is adhered to the exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding
Implementation Method 3
the external portion of the at least one leaflet is adhered to the exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding
Data Source
AI summary
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit prosthesis including a valved conduit subassembly within a secondary conduit. The valved conduit subassembly include at least one leaflet that is coupled to an exterior surface of a primary conduit.